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When do School-aged Patients Return to School After ACL Surgery?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03929237
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : February 7, 2022
Sponsor:
Collaborators:
University of Michigan
University of Pittsburgh
Information provided by (Responsible Party):
Scott Kaar, MD, St. Louis University

Study Description
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Brief Summary:
We intend to survey school aged patients following ACL surgery on when they return to school. We will analyze independent variables to determine if any relationship exists that may influence the amount of time missed.

Condition or disease Intervention/treatment
ACL Reconstruction Other: observe when return to school after surgery

Detailed Description:
All patients undergoing ACL surgery who are enrolled in middle or high school will be recruited for study participation. Patients undergoing concomitant additional ligament surgery will be excluded. The only procedure will be to answer a short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them. This will occur at the patient's 2 week post-operative clinic visit. This clinic visit is a standard of care visit. Independent variables will be collected from the medical record and are all standard of care information routinely collected from this patient populations (age, sex, race, date of surgery, surgeon, sport played, grade, ACL surgery graft type, associated meniscal or chondral surgery, length of post-operative narcotic use, regional nerve block at the time of surgery, SANE score, IKDC score, brace used).
Study Design
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: When do School-aged Patients Return to School After ACL Surgery?
Actual Study Start Date : April 18, 2019
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021
Groups and Cohorts
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Intervention Details:
  • Other: observe when return to school after surgery
    Short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them

Outcome Measures
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Primary Outcome Measures :
  1. When return to school after surgery [ Time Frame: 1-2 weeks post-operatively ]
    days from surgery to return to school


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
School aged patients who undergo ACL reconstruction surgery during the school year
Criteria

Inclusion Criteria:

  • ACL reconstruction surgery
  • currently enrolled in middle or high school (grades 6-12)
  • Surgery occurs during the school year
  • No concomitant additional ligament surgery (ie. PCL, MCL, LCL or MPFL)

Exclusion Criteria:

  • patient is home schooled or in non-traditional school setting (ie. school for special needs)
  • concomitant additional ligament surgery
  • surgery occurs outside of the school year or on a scheduled break from school
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929237


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
SSM Health Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
University of Michigan
University of Pittsburgh
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Scott Kaar, MD, Associate Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT03929237    
Other Study ID Numbers: 29979
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No